Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02964390 |
Other study ID # |
002 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2013 |
Est. completion date |
December 2023 |
Study information
Verified date |
August 2021 |
Source |
Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med |
Contact |
Marcin Kurzyna, MD, PhD |
Phone |
+48-22-7103052 |
Email |
marcin.kurzyna[@]ecz-otwock.pl |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for
non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).
The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified
from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.
This is a interventional study analyzing the benefits and the risk of BPA. Clinical
evaluation, including: functional capacity, 6-minutes walking test, haemodynamics,
biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL
assessment with Short Form 36 (SF36) questionnaire was performed before the initiation
therapy of BPA, and 3-6 months after last session of BPA.
Description:
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially
life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise
differential diagnosis, long life anticoagulation when confirmed and qualification for
surgical treatment by an experienced multidisciplinary team. The gold standard of treatment
in operable patients is pulmonary endarterectomy (PEA), which is highly effective in
restoring functional status and improving life expectancy. Nevertheless, even in the leading
CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim
perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty
(BPA) has emerged as a promising new interventional option in non-operable CTEPH.
The development BPA was far from rapid. It took 13 years from the first case-report to the
publication of a first series of 17 patients treated with BPA in Boston/US and another 13
years until the results of first European series of 20 patients has been reported from
Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013,
motivated by their expected poor prognosis, when compared to those to whom surgical PEA was
offered.
The aim of this study is an analysis of efficacy and safety of BPA procedure.
The BPA is performed by two senior interventional specialist - cardiologist and radiologist
with extensive experience in coronary, pulmonary and general vessel interventions supported
by perfusion nurse. All patients undergoing BPA are given informed consent before the first
BPA intervention. The limited experience with and experimental nature of BPA are emphasised
to candidates.
A standard BPA procedure is typically performed from the right femoral vein, with
anticoagulation of unfractionated heparin in periprocedural period. A long (70 or 90 cm)
sheath is introduced into the pulmonary trunk with support of pigtail catheter. Selective and
super-selective catheterisation of lobar arteries, segmental and when appropriate
subsegmental arteries is performed to demonstrate variety of clots: "webs", "rings",
"occlusions", "pouch" lesions and reduction of parenchymal opacification after injection of
vascular contrast medium. Balloon catheters (diameter 1.25-6.0 mm) are positioned over the
selected lesion and dilated for several seconds. Immediate selective angiography is performed
after dilation to confirm satisfactory results which presented the improvement of contrast
medium distribution and venous return. Control angiography is done to rule out residual
stenosis or signs of vessel injury. Following BPA procedure, patients are moved to ICU for 48
h surveillance.
Right before the initiation of BPA and during 3-6 months after last session, a full workup is
made, including: World Health Organization (WHO) functional class, 6-minute walking test
(6MWT), concentration of biomarkers (NT-proBNP, Troponin T, sST2), cardiopulmonary exercise
test, echocardiography, electrocardiography and right heart catheterization including
measurements of right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary
capillary wedge pressure (PCWP), cardiac output (CO), cardiac index (CI), pulmonary vascular
resistance (PVR), mixed venous oxygenation (MVsat.O2) and systemic oxygenation (AOsatO2).
Additionally patients fill in the Short Form 36 (SF36) quality of life questionnaire before
initiation of BPA and 3-6 months after last session.